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Summit Porocoat

FDA UDI

Class III (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name
SUMMIT POROCOAT FDA UDI
Generic Name
Coated femoral stem prosthesis, one-piece FDA UDI
Device Name
SUMMIT FEMORAL STEM 12/14 TAPER TAPER ED w/POROCOAT SIZE 9 STD 165mm FDA UDI
Model / Reference
1570-01-165 FDA UDI
Description
SUMMIT FEMORAL STEM 12/14 TAPER TAPER ED w/POROCOAT SIZE 9 STD 165mm FDA UDI

Identifiers

Catalog Number
157001165 FDA UDI
Primary DI / UDI-DI
10603295059400 FDA UDI
FDA Product Code
MRA FDA UDI
LPH FDA UDI
JDI FDA UDI
LZO FDA UDI
GMDN Term
Coated femoral stem prosthesis, one-piece FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
888.3358 FDA UDI
888.3350 FDA UDI
888.3353 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coated femoral stem prosthesis, one-piece

Summit Porocoat by Depuy Orthopaedics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated femoral stem prosthesis, one-piece.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy Orthopaedics, Inc.

Sources (1)

  • FDA UDI 2a73874c-98c5-4336-a9bc-d9a2846fbf4c 35 fields · synced Jun 8, 2026